An interventional study of Standard of Care with EASY DSS and Standard of Care without EASY DSS in Type 2 Diabetes Mellitus, sponsored by Läkarexpressen AB. Completed at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-05.
Sponsored by Läkarexpressen AB · Not applicable, Interventional, and Treatment
A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic outcomes of individualized treatment support in patients with type 2 diabetes. The primary objective of the trial is to confirm the superiority of standard of care with EASY DSS versus standard of care without EASY DSS in terms of glycemic control in patients with type 2 diabetes with ongoing treatment with any antidiabetic drug(s).
Exclusion Criteria:
Patients will receive standard of care with a board certified physician with EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.
Device: Standard of Care with EASY DSS
Patients will receive standard of care with a board certified physician without EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.
Other: Standard of Care without EASY DSS
The EASY DSS is a software tool designed to process and analyze data to facilitate individualized treatment suggestions for type 2 diabetes patients. Patients will receive standard of care with a board certified physician with EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.
Patients will receive standard of care with a board certified physician without EASY DSS. The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone.
HbA1c
Change from baseline HbA1c
Time frame: 26 weeks
Fasting plasma glucose
Change from baseline in fasting plasma glucose (FPG)
Time frame: 26 weeks
Achieving treatment target
Meeting treatment target of HbA1c \< 7% (53 mmol/mol)
Time frame: 26 weeks
Hypoglycemia
Meeting treatment target of HbA1c \< 7% (53 mmol/mol) without severe or clinically significant hypoglycemic episodes
Time frame: 26 weeks
Plan to share: No
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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